Food Law

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Key Points

This page outlines key points to introduce (or summarize) food safety law. Use these points as an introduction to the overall topic of food law and as a review as you complete your study of food law.

 

 

 

 

 

 

Observations

Several observations about the food industry may help describe a framework for food law.  Most of these points are addressed in more detail throughout these materials.  Use this page as an introduction or summary of key points that are emphasized in subsequent materials.

There is a difference between policy and law.  Law emphasizes "what is the law at this time."  Policy discusses "what people think the law should be."  This course is primarily a law course, that is, what is the law at this time.  This course will infrequently discuss policy, that is, what we think the law should be.

 

a)  Global industrialization since the late 1700s (i.e., advancing production, transportation and information technologies) has allowed a large number of persons to pursue non-agricultural careers and has allowed agriculturalists to provide food for persons who do not produce their own food.  The following points suggest some consequences of industrialization.

  • Many food consumers rely on others to produce their food.
  • Consumers in the United States and several other nations have the economic ability to be selective in what food they consume.
    • See Table 7 of "Food Expenditures" by USDA Economic Research Service (ERS) at http://www.ers.usda.gov/data-products/food-expenditures.aspx.  Note that on the average, the United States has spent less than 10% of its income on food since 2000.  Few other nations come close to this relatively low cost for food.  Such low-cost food allows consumers to be selective in which foods that purchase and consume.  This selectivity also is apparent in the laws enacted in the nation.
    • Several European nations are close to the United States in terms of low-cost food, but European nations are often more strict in terms of their expectations for the food industry.  This point is discussed several times in the subsequent materials.
    • When consumer income allows demand to exceed producers' supply, producers enjoy extra profit, such as the "Golden Age of Agriculture"  (1910-1915).  When advancing production technology allows producers to increase supply, prices drop and consumers enjoy a higher standard of living.  Rather than consuming more food (because we can only eat so much), consumers become more selective in which food they consume.
  • Food moves through a series of steps from production to consumption: e.g., production, transportation, storage, processing, further transportation and storage, retail sale for at-home preparation, and food service preparation.  Many people are involved in the production and handling of any food item that a consumer eats.
  • Food is at risk of becoming unsafe at any of these steps as a result of natural processes (e.g., spoilage), careless practices (e.g. improper production, processing or handling practices), or intentional contamination to render the product unsafe (i.e., terrorism).
  • Every entity in the food system must act to minimize the risk of food becoming unsafe during the time that the entity controls the food.
  • It would be too expensive to devise a food industry that can guarantee safe food; the realistic approach is to minimize the risk of unsafe food.

 

b)  Government oversight of food in the United States involves three levels:  federal, state and local.

  • At the state and federal levels of U.S. government, the three branches of government are involved in oversight of the food industry:  legislative, executive, and judicial.
  • Each branch of government creates its own type of law:  statute (enacted by legislative branch), regulation (promulgated by the executive branch), and common law (court opinions rendered by the judicial branch).
    • The legislative branch of U.S. government (e.g., the U.S. Congress at the federal level of U.S. government) is comprised of elected officials who set public policy by enacting statutory laws.
    • The executive branch of U.S. government is comprised of government agencies (such as the Food and Drug Administrations and the USDA Food Safety Inspection Service) and their employees whose task is to implement the statutory programs that have been enacted by the legislative branch.  The agencies of the executive branch promulgate or set forth regulations that provide details as to how the agency will implement the statutory program.
    • The judicial branch of U.S. government (that is, the court system) resolves legal disputes and interprets the law, that is, the Constitution, statutes, and regulations.

 

c) Outside the United States, most nations also have established rules for reducing the risk of unsafe food in their country.

  • Food is subject to the laws of the jurisdiction where the food is located. As food is moved from one nation to another, the food is subject to the laws of each nation in which it has been located.
  • Nations interested in international trade of food collaborate with potential trading partners to establish product standards and oversight practices to minimize the cost of reducing the risk of unsafe food in the global market (this collaborative effort is often referred to as harmonization).
  • Firms interested in selling food in more than one nation must be familiar with and comply with the laws of each nation even if the food will be processed in only one nation before it is transported (exported) to another nation for sale to consumers.

 

d)  Food safety is not the same as food quality.  Quality focuses on the characteristics of the food, such as taste, texture or appearance.  Food safety focuses on whether the food would cause the consumer to become ill.  Food businesses consider both the quality and safety of their food products; food regulators focus on safety.

  • These materials focus on food safety; these materials DO NOT address food quality.
  • Food security focuses on the quantity and nutritional value of food -- an issue often overlooked in the United States and other developed nations.  But every nation -- every society -- has people without an adequate food supply. Food security is NOT addressed in these materials.

 

e) The primary strategy for enforcing food laws is to prevent food from being sold if the food does not comply with the law.  Fines and other criminal penalties are primarily imposed only if the food business refuses to remove non-complying food from the market or continues to operate the business without regard for the safety of the consumer.

 

f)  Businesses in the food industry also are influenced by market forces; fundamentally, a firm that provides unsafe food is liable for injuries suffered by a consumer.

  • Businesses involved in the chain of events that led to unsafe food will attempt to determine which business caused the unsafe food and shift the liability to that business.
  • Actions that food businesses can take to reduce the risk of liability include 1) developing and implementing practices that reduce the risk of unsafe food, 2) maintaining records of production practices, 3) maintaining records of suppliers and buyers of food products as the products move through the food system, and 4) establishing and enforcing expectations upon suppliers.
  • Agricultural commodity producers are increasingly being expected (by consumers, and thus processors) to not only implement and document production practices that reduce the risk of unsafe food, but also practices that reduce the risk of adverse environmental and social consequences.

 

Key Points

Based on these observations, key points about food law can be suggested.

1.  Food laws will not guarantee that food is safe; it is too expensive to guarantee that all food is safe for consumption.  The less expensive approach, but still politically and socially accepted, is for food laws to reduce the risk of unsafe food.

  • To understand the risk of unsafe food and to manage that risk requires an application of science, such as biology, microbiology, chemistry, pathology, engineering, etc.
  • Despite common expectations for all foods and all food businesses, each type of food needs specific, unique or individualized production, processing and handling practices to reduce the risk that the food is rendered unsafe.
  • Strategies to reduce the risk of unsafe food must be developed and implemented at each step in the food system.
    • Consider the extent to which these strategies need to be coordinated throughout the food system.
  • Three components of risk analysis as it relates to food safety are risk assessment, risk management and risk communication.

 

2.  U.S. food law has defined the food industry into sectors:

  • consumers,
  • retail and food service sector (e.g., grocery stores, restaurants, cafeterias),
  • processing sector (e.g., food businesses that manufacture/process, transport and store food products),
  • production sector which produces agricultural commodities (e.g., farms, ranches, orchards, vineyards, feedlots), and
  • the production input sector that provides agricultural producers with animal drugs, animal feed, pesticides, and biotechnology.

These categories may not have been explicitly intended but have emerged as U.S. food law has evolved since the late 1800s.

 

3.  Government oversight of the sectors can be summarized as follows; note that the government oversight strategy varies by sector and the oversight strategies are changing.  A graphic summary of the sectors and strategies also is available.

  • Consumers -- the primary strategies to advance food safety are 1) educate the consumers about food safety (and nutrition) and 2) provide information so consumers can make informed decisions.  Consumers decide whether to participate in educational programs; federal, state and municipal laws direct what information food businesses must provide consumers -- usually as part of the label on the food product. Consumers also decide what food they will consume and how they will handle the food.  Government will not regulate how consumers handle and prepare food in their home, for example.
  • Retail and food service sector -- primarily regulated by state law and municipal health codes with increasing guidance from the federal level via the Food and Drug Administration (e.g., the Food Code).
  • Processing sector -- primarily regulated by U.S. federal law since the early 1900s in coordination with state law and municipal health codes.  The primary U.S. federal agencies are 1) the U.S. Food and Drug Administration (FDA) and 2) the Food Safety Inspection Service (FSIS) in the U.S. Department of Agriculture (USDA). Hazard Analysis and Critical Control Point (HACCP) is emerging as the dominant strategy.  The recently defined Food Safety Plan is based on the principles of HACCP.
  • Production sector -- the primary strategy has been to educate producers so the agricultural commodities are safe for consumption; the educational programs have been facilitated by federal agencies and state universities.  The guideline is for producers to implement good agricultural practices (GAP).  However, this strategy is evolving to include 1) additional direct government regulation and 2) additional influence from processors who insist that producers follow steps to reduce the risk that agricultural commodities are unsafe for consumption. HACCP principles are also emerging as the foundation for GAP.
  • Production input sector -- agricultural production inputs that could impact the safety of the final food product are extensively regulated by federal law, such as animal drugs, pesticides, and biotechnology.  Feed for food animals (e.g., bovines and swine) and companion animals (e.g., cats and dogs) also are subject to safety standards.

 

4. Federal law dominates the regulation of food safety in the United States but there is close interaction with state and local authorities, plus an expanding role and impact of international food standards.

  • The basic approach to addressing food safety has not changed much over the past 100 years since the first U.S. federal laws were adopted in the early 1900s, but the laws have been refined/amended.
  • The major prohibitions in food safety laws are the sale of adulterated or misbranded food products; adulterated and misbranded have broad definitions and address a number of food safety concerns.
  • Firms also are prohibited from selling food products if they do not appropriately document where and how food is handled; for example, registering the food facility and developing/implementing a Food Safety/HACCP plan.

 

5.  It is the task or burden of the food business to establish that the food is NOT adulterated or misbranded. It is not the government's responsibility to establish that food is adulterated or misbranded.  As long as there is a reasonable belief that the food is adulterated or misbranded, the response will be to separate the food from consumers.  It is up to the food company to then establish that the food is not adulterated or misbranded, and that the food can again be made accessible to consumers.

  • Rather than establishing a long list of what food businesses (especially food processors) cannot do, the U.S. federal law broadly prohibits the adulteration and misbranding of food.  The U.S. federal regulations then specify what the food businesses can or must do to prevent their product from being considered adulterated or misbranded. If the firm cannot establish that it has met the standards, the food is considered adulterated or misbranded, and cannot be sold.

 

6. Food must be in compliance with the laws of the jurisdiction where the food is located.

  • Food that is moved among government jurisdictions (such as food that is transported from one nation to another nation) is subject to more than one set of food laws. Complying with more than one set of requirements can complicate the movement of food among jurisdictions.
  • Nations are trying to harmonize their food laws to reduce the challenge for food businesses to comply with a variety of food laws, and thereby advance the availability of food through international trade.

 

7. The two U.S. federal agencies with primary responsibility for food safety in the United States are

The Environmental Protection Agency also has an expanding role (see EPA's discussion of the Food Quality Protection Act). In addition, the Food Safety Office in the Centers for Disease Control and Prevention (CDC) provides information about food-borne illnesses and responds to outbreaks of food-borne illnesses.

  • The FSIS/USDA has primary responsibility for meat, poultry, and eggs; FDA has primary responsibility for most other food products.  The line defining the jurisdictions between these two agencies feels blurred in some situations.

"FDA's responsibility in the food area generally covers all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which are under the authority of the U.S. Department of Agriculture (USDA's Food Safety and Inspection Service (FSIS), the labeling of alcoholic beverages (above 7% alcohol) and tobacco, which are regulated by the U.S. Department of the Treasury's Bureau of Alcohol, Tobacco, and Firearms (ATF), and the U.S. Environmental Protection Agency (EPA), which establishes tolerances for pesticide residues in foods and ensures the safety of drinking water." Excerpt from Center for Food Safety and Applied Nutrition [this web page is no longer active].

See Who Inspects What? A Food Safety Scramble and Dual Jurisdiction: Also in Need of ‘Modernization’

  • On some issues, Congress expects FDA and FSIS/USDA to use similar approaches (such as defining adulterated); on other issues, Congress has mandated that the two agencies use very different approaches (e.g., inspections of processing firms and food products).

 

8. The initial focus of U.S. food safety laws in the early 1900s was on manufactured or processed food products. That is still a major emphasis today, but with the increased understanding that food can become unsafe at many different points in the food system, the focus of food safety is expanding to encompass production of agriculture commodities and final food preparation. The need to address food safety extends from farm-to-table.

    • "In addition to a focus on public health, another important principle on which all of our food safety activities are based is the need to take a farm-to-table approach." Excerpt from Principles Underlying the USDA Food Safety Strategy.
    • For example, consider all the persons involved in producing a pizza. The primary ingredients may be cheese, ground beef, pork sausage, tomato sauce, spices, green peppers, mushrooms, olive oil and crust.

Now think about the steps involved with each ingredient.

      • Olives grown in Italy, processed into oil, transported to the United States, stored and moved again; finally the package is opened and the oil applied to the crust.
      • Wheat is grown on a North Dakota farm, transported to the elevator, shipped by rail to a mill for grinding; the flour is trucked to the frozen dough processing firm where it is mixed with water and other ingredients, packaged and frozen; the dough is then sent to the pizza manufacturing business.
      • The calf is born in Montana, backgrounded in South Dakota with 1,200 other calves, and finished with 10,000 feeders in Kansas; it is slaughtered in Nebraska and the meat is shipped to Texas where it is combined with meat from Arkansas, ground and shipped to the pizza manufacturing business.
      • The tomato is raised in California (or Spain), processed into paste, transported to ...

And the list goes on -- also consider the pig, green pepper, mushroom, spices, and especially the cheese (that is, the dairy industry). How many dozens of processes, businesses, and people are involved in producing the pizza? Each step (production, processing, packaging, storage, transportation) could render the final product unsafe. How do we assure the pizza will not make the consumer ill?

    • The safety of food cannot be guaranteed or fully assured. Achieving that level of safety is too expensive. The best that can be done at this time is to reduce the likelihood or risk of a food-related health problem. Perhaps the last question in the previous paragraph should read "how do we minimize the risk that the pizza may make the consumer ill?"

 

9. Decisions about what to eat will be made by the consumer, not a government authority; but the law requires that information about the food product be available so consumers can make an informed choice.

 

10. Government inspection of the food industry continues to be an important strategy, but one must understand the recent and ongoing shift of responsibility to the firms with the adoption of Hazardous Analysis and Critical Control Points (HACCP) plan requirements.

HACCP can perhaps be summarized as assessing the risk of unsafe food, managing those risks, and appropriately communicating those risks to consumers, in both an effort to prevent unsafe food and to respond in case of unsafe food.

Since the 1990s, several federal laws mandated that certain food businesses (i.e., meat, poultry, juice and seafood) develop and implement a HACCP plan.  The more recent Food Safety Modernization Act completes that mandate by requiring all other food processors develop and implement a Food Safety Plan. 

  • Remember:  HACCP and Food Safety Plans are underpinned by nearly identical food safety principles.

 

11. Other U.S. federal agencies have a role in addressing food safety concerns; e.g., Federal Trade Commission, Animal and Plant Health Inspection Service, Agricultural Marketing Service, National Marine Fisheries Service, and Customs & Border Protection.

  • Likewise, the role of state and local authorities in addressing food safety cannot be overlooked, e.g., Food Code.
  • In addition, global trade of agriculture commodities and food products raises issues about accepting imports and preparing to export.

 

12. As stated previously, it is too expensive to guarantee that food is safe. The alternative is to strive to reduce the risk that the food is unsafe. Since the 1990s, much has been written about addressing food safety on the basis of Risk Analysis. The following statements introduce this concept.

“The risk analysis process comprises three separate elements: risk assessment, risk management and risk communication. It is widely recognized as the fundamental methodology underlying the development of food safety standards. Decisions are needed to determine what the hazards are and to identify their immediate, interim and long-term effects on human health (risk assessment); to establish the appropriate measures of control to prevent, reduce or minimize these risks (risk management); and to determine the best way to communicate this information to the affected population (risk communication).” Excerpt from http://www.fao.org/docrep/w8088e/w8088e07.htm.

 

13. Two other thoughts that are increasingly underpinning the effort to minimize the risk of a food-borne illness: 1) our efforts to minimize risk are based on our understanding of science and 2) food firms are increasingly expected to maintain sufficient information (records) to track the movement and handling of a food product through the food industry (traceability).

  • Are the legal requirements imposed on the food industry the result of our understanding of science or are some legal restrictions motivated by economic and political interests?
  • Will there be times when Region A restricts the movement of food from Region B and the stated reason is to protect consumers in Region A from unsafe food from Region B but the unstated reason is to protect food producers in Region A from the competition of food producers in Region B?

 

 

 

 

 

Closing thought: 

Standards for the food industry arise from both industry expectations and government regulations.  The next several topics generally explain the structure of U.S. government.  A fundamental understanding of this structure will help explain how food standards are incorporated into U.S. law.

Students:  can you begin to relate these "Key Points" mentioned on this page to the food product you want to emphasize or focus on during this course?

Students:  this page provides a broad overview of food law.  As you study the remaining materials, recognize that you are adding details to general outline.  You are encouraged to ask yourself "how do the specific topics being studied fit into the overall organization of food law suggested by the overview on this page?"

 

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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